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Completed

NCT Number: NCT05372536

Home Chemotherapy Intervention for Children With Cancer - a Feasibility Study

Children with cancer undergo intensive treatment with many serious side effects and frequent in- and outpatient visits. Studies show that the frequent hospitalizations are very disruptive to children and their families, who strive to maintain a normal everyday life. The aim of the study is to test a parent-led home-administered low-dose cytarabine intervention that will not compromise the quality of treatment and care, increase the caregiver burden or the experienced symptoms of the children. The methodical approach is based on The Medical Research Council's framework to develop and evaluate complex interventions in health care using both clinical observational methods, participatory methods, surveys and qualitative ethnographic methods. The overall goal of the project is to support and ease the everyday lives of children with cancer and their families during the intensive treatment periods.

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Key information

Conditions

Supportive Care Childhood Cancer Neoplasms

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louise Ingerslev Roug

Copenhagen, Danmark, 2100, Denmark

About this study

This single-arm feasibility study is conducted at Copenhagen University Hospital, Rigshospitalet, in Denmark at the Department of Pediatric Oncology and Hematology.The PI started to recruit participants March 2022. Patients with Acute Lymphoblastic Leukemia (ALL), Philadelphia positive Acute Lymphoblastic Leukemia (PH+ALL) and Lymphoblastic Lymphoma (LBL) are eligible for inclusion if their parents speak and understand Danish or English, able to manage basic treatment and care such as oral medication, mobilization, nutrition, central venous catheter care and practice good personal hygiene. The parents' competences are assessed by the PI in collaboration with a team of project- and ward nurses who know them. Participants are recruited between day 15 and 29 from diagnosis. Parents to eligible participants and adolescents aged 15+ receive oral and written information and provide written informed consent before inclusion. Children and adolescents less than 15 years of age receive oral information and provide oral consent if possible according to their age. Parents to the included participants are offered to administer the protocolized low-dose bolus (injection) Cytarabine in their children's CVCs at home. The administration procedure is developed as a simple and safe non-touch technique. The parents receive a video and paper-based guideline and information material followed by a 3-step nurse-led education program. The parents can administer the Cytarabine at home when they (and the child/adolescent) feel safe and comfortable managing the procedure and when the nurses are sure that the parents can manage the procedure at home. The first dose of Cytarabine is always administered at the hospital.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children/adolescents diagnosed with ALL, LBL or PH+ ALL

Exclusion criteria

  • If their parents did not understand, read and speak Danish
  • If the parents did not manage the children/adolescents' basic care and treatment needs (CVC care, oral medication, hygiene, nutrition, mobilization, ect.)

Treatment and study plan

parent-led home-administered low-dose Cytarabine

Other

Parents to the included participants are offered to administer the protocolized low-dose bolus (injection) Cytarabine in their children's CVCs at home. The administration procedure is developed as a simple and safe non-touch technique. The parents receive a video and paper-based guideline and information material followed by a 3-step nurse-led education program. The parents can administer the Cytarabine at home when they (and the child/adolescent) feel safe and comfortable managing the procedure and when the nurses are sure that the parents can manage the procedure at home. The first dose of Cytarabine is always administered at the hospital.

Primary outcomes

  1. Recruitment rate

    Time frame: From day 15 (from protocol start) until the last day with low dose cytarabine treatment which depends on protocol stratification and randomization (mean intervention period = 22 weeks)

    Number of families who consent to participate in the study

  2. Attrition rate

    Time frame: From time of obtained consent until end of intervention period (mean intervention period = 22 weeks)

    Number of drop-outs during the intervention

  3. Demand (dose)

    Time frame: From day 38 up to day 167 from protocol start. Four to eight timepoints depending on number of protocolized cytarabine doses (mean intervention period = 22 weeks)

    Number of parent-led home-administered low-dose Cytarabine (total and average)

  4. Education time

    Time frame: From time of obtained consent until start of intervention (2-4 weeks)

    Time (minutes) nurses spent on education for parents before the intervention

  5. Adverse events

    Time frame: From recruitment start to end of intervention (mean intervention period = 22 weeks)

    Severe and non-severe events

  6. Respons rate

    Time frame: Everyday during each four-day-long chemo-cycle to five days after (one to eight cycles are given depending on the specific protocol).The typical intervention period is 22 weeks

    Number of responses on PENAT questionnaire

  7. Respons rate

    Time frame: At the end of each chemo-cycle (day 4, each chemo-cycle is four days). The typical intervention period is 22 weeks

    Number of responses on CMCC and SS questionnaires

Secondary outcomes

  1. Nausea and Vomiting during low-dose Cytarabine treatment (tentative)

    Time frame: Starting day one of the Cytarabine cycle and stops five days after (9 days). Each Cytarabine cycle is four days. There can be from four to eight cycles of Cytarabine in the Protocol.

    Questionnaire (PENAT - measuring chemotherapy induced nausea and vomiting))

  2. Caregiver Demands (tentative)

    Time frame: Day four (and the last day) of each cycle of Cytarabine (each cycle is four days)

    Questionnaire (CMCC: Care of My Child with Cancer)

  3. Satisfaction and safety (tentative)

    Time frame: Day four (and the last day) of each cycle of Cytarabine (each cycle is four days)

    Questionnaire measuring parents and children/adolescents' experience of satisfaction and safety managing the home-administration of Cytarabine)

  4. The family's experience of the intervention of home-administered Cytarabine

    Time frame: Interviews are conducted after end intervention (approximately day 167 since protocol start)

    qualitative interviews with parents and children/adolescents

  5. Adaption, Integration, implementation

    Time frame: Fieldnotes are collected at various timepoints during the in total study/intervention period = 43 weeks

    Qualitative process evaluation of the feasibility areas: Adaption, integration and implementation

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Parent-Administered Low-Dose Cytarabine to Children and Adolescents With Cancer at Home - a Feasibility Study

Acronym: INTACTatHome

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 12, 2022
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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